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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02622750
Other study ID # CLW2015AD2
Secondary ID
Status Recruiting
Phase Early Phase 1
First received November 19, 2015
Last updated November 15, 2017
Start date November 1, 2016
Est. completion date March 31, 2019

Study information

Verified date December 2015
Source Fujian Medical University
Contact Liang-Wan Chen, M.D PH.D
Phone 86 13358255333
Email daixiaofu719@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare triple-branched stent placement with total-arch replacement in the treatment of acute DeBakey I aortic dissection . The investigators design optimal effect compare prospective, multi-center, randomized, open-label, parallel-group, non-inferiority clinical trial.


Description:

From November 2015, 90 consecutive patients with acute DeBakey I aortic dissection from five-centers in China were treated with triple-branched stent placement or hemi-arch replacement. The distribution of the patients adopts the dynamic random variance minimization random method. About half of the patients will be assigned to the the stent-graft group, the other to the hemi-arch group.

In all cases, surgery was performed under general anesthesia with tracheal intubation and cardiopulmonary bypass (CPB). During surgery arterial pressures at the upper and lower limbs were monitored. An esophageal echocardiography probe was placed routinely, and a sternal incision was performed. To establish CPB, the perfusion tube was placed in the right axillary artery and the drainage tube was placed in the superior and inferior vena cava through the right atrium. The CPB flow rate was of 2.4-2.6 L/kg/min. Intermittent cold blood cardioplegia was perfused through the left and right coronary arteries for myocardial protection.

In stent-graft group , the innominate artery and the left common carotid artery were fully isolated during the CPB cooling process. The ascending aorta proximal to the innominate artery was occluded, and the ascending aorta was transected slightly above the sinus tube connection; the left and right coronary arteries were directly perfused with blood-containing cold cardioplegia. Proximal procedures such as aortic valve repair, sinus reconstruction, and root replacement were performed first. Afterwards, the stumps were reconstructed. The reconstructed aortic root stump was anastomosed with a Dacron graft of corresponding size using 4-0 polypropylene suture (ascending aorta replacement). The nasopharyngeal temperature was then decreased to 25° (usually a rectal temperature of 27-29°C), the aortic perfusion flow was set to 10-15 ml/kg/min, and the innominate artery and the left common carotid artery were occluded 5-6 cm above the aortic arch. The aortic occlusion clamp was removed and a half aortic arch transection was made about 2 cm proximal to the innominate artery. Through the incision, the true lumens of the aortic arch, the proximal descending aorta, and the three aortic branches were identified. The triple-branched stent graft was inserted into the true lumens of the aortic arch and proximal descending aorta; the three stent graft branches were then placed into the corresponding true lumens of the aortic arch branch vessels followed by the sequential release of the vascular stent backbone and the branch stents in the left subclavian artery, the left common carotid artery, and the innominate artery. A catheter with a balloon or a probe was used to expand the vascular stents and the graft and branches were examined for kinks or folding of the backbone. A sandwich reconstruction was performed between the aortic stump, the aortic external Dacron graft, and the proximal stentless suture zone of the intraluminal artificial vessel backbone. The reconstructed stump was anastomosed with the Dacron graft that replaced the ascending aorta using 4-0 polypropylene suture. The occlusions of the left common carotid artery and the innominate artery were then relieved, and air was fully flushed out from the heart and the aorta. The right axillary artery perfusion was stopped, and systemic perfusion via an aortic perfusion tube at the artificial portion of the ascending aorta was performed. The patient was rewarmed after oxygen debt repayment, followed by the cardiac resuscitation.

In total-arch group , the ascending aorta proximal to the innominate artery was blocked during the CPB cooling process, and the ascending aorta was incised and transected slightly above the sinus tube connection. The left and right coronary arteries were directly perfused with blood-containing cold cardioplegia. As in stent-graft group , proximal procedures were performed first. The reconstructed aortic root stumps were sutured with Dacron graft using 4-0 polypropylene suture (ascending aorta replacement). The nasopharyngeal temperature was then decreased to 25° (usually a rectal temperature of 27-29°C) and the aortic perfusion flow was set to 10-15 ml/kg/min. The innominate artery and the left common carotid artery were clamped 5-6 cm above the aortic arch and the aortic occlusion clamp was removed. Half aortic arch resection was performed along the greater curvature of the aortic arch at 1 cm proximal of the innominate artery to the lesser curvature of the aortic arch at the origin of the descending aorta. Stumps between the dissection slices were lined with cotta slices and reconstructed using the sandwich method and then anastomosed with an Dacron graft of the corresponding size and shape using 4-0 polypropylene suture. Finally, the proximal end was anastomosed with the artificial blood vessel using 4-0 polypropylene suture. Air was fully flushed from the heart and aorta. The right auxiliary artery perfusion was stopped and systemic perfusion via an aortic perfusion tube at the artificial blood vessel of the ascending aorta was performed. The patient was rewarmed after oxygen debt repayment, followed by cardiac resuscitation.

Telephone contact was maintained with the patients after discharge. At 3,6,12 months postoperatively , patients received a follow-up examination, chest radiography, echocardiography, bilateral carotid artery Doppler examinations and CT angiography (CTA) examinations Numerical data were expressed as percentages, and comparisons between groups were performed with the chi-square test. Quantitative data were expressed as mean ± standard deviation; the independent sample t test was used for group comparisons and the paired t-test was used to compare the groups before and after surgery. The primary end point is the occluded rate of the false lumen one year postoperatively. The secondary end point are the survive rate ,complication, reoperation rate, the growth rate of thoracic descending aorta, security index perioperatively, life quality postoperatively.Statistical analysis were performed with SPSS 11.5 software. A value of P < 0.05 was considered statistically significant.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date March 31, 2019
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- age<65 years

- acute DeBakkey I aortic dissection is confirmed by CTA

- cardiac function is NYHA I-II

- the onset time< 2 weeks

- the patient or family members can understand the research plan and will participate in this study and provide a written informed consent

Exclusion Criteria:

- Dissection involved the superior mesenteric artery, renal artery and coronary artery, which affect the body's viscera function seriously. The principal researcher from different centre need judge the patients' condition.

- there is a serious complication of nervous system, such as coma, paraplegia, etc

- pregnant or lactating women

- anyone with severe emphysema, interstitial pneumonia or ischemic heart disease cannot tolerate surgery

- subjects with contraindications of heart surgery, anesthesia and extracorporeal circulation

- subjects had significant or progressive of heart disease, according to the experience of the researchers,whose life expectancy is less than 1 year, or placement of triple- branched stent graft will induce unacceptable risk to the subjects

- anyone with serious mental illness, drug abuse, alcoholism, prison inmates, a lack of ability to care for, or can not express the informed consent

- subjects are incompliance or can't complete the research

- anyone is involved in the other clinical trial

- other reasons are not suitable for clinical trials, according to the researchers

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
triple-branched stent graft
place the triple-branched stent graft into the aortic arch, descending aorta ,the left subclavian artery, the left common carotid artery, and the innominate artery.
four-branched Dacron graft
The stent elephant trunk was inserted into the true lumen of the distal aorta in a bound, compressed state after the distal aorta was transected between the origin of the left subclavian artery and the left carotid artery. The distal aorta incorporating the stent graft was firmly attached to the distal end of the four-branched Dacron graft using the "open" aortic procedure. After the anastomosis was completed, blood perfusion of the lower body was started via the perfusion limb of the four-branched Dacron graft.

Locations

Country Name City State
China the Department of Cardiovascular Surgery FuZhou Fujian

Sponsors (6)

Lead Sponsor Collaborator
Liang-Wan Chen MD First Affiliated Hospital of Zhongshan Medical University, Longyan City First Hospital, RenJi Hospital, The First City Hospital, ZhanZhou, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (24)

Chen LW, Dai XF, Lu L, Zhang GC, Cao H. Extensive primary repair of the thoracic aorta in acute type a aortic dissection by means of ascending aorta replacement combined with open placement of triple-branched stent graft: early results. Circulation. 2010 Oct 5;122(14):1373-8. doi: 10.1161/CIRCULATIONAHA.110.946012. Epub 2010 Sep 20. — View Citation

Chen LW, Wu XJ, Lu L, Zhang GC, Yang GF, Yang ZW, Dong Y, Cao H, Chen Q. Total arch repair for acute type A aortic dissection with 2 modified techniques: open single-branched stent graft placement and reinforcement of the dissected arch vessel stump with stent graft. Circulation. 2011 Jun 7;123(22):2536-41. doi: 10.1161/CIRCULATIONAHA.110.008656. Epub 2011 May 16. — View Citation

Chiappini B, Schepens M, Tan E, Dell' Amore A, Morshuis W, Dossche K, Bergonzini M, Camurri N, Reggiani LB, Marinelli G, Di Bartolomeo R. Early and late outcomes of acute type A aortic dissection: analysis of risk factors in 487 consecutive patients. Eur Heart J. 2005 Jan;26(2):180-6. Epub 2004 Dec 7. — View Citation

Crawford ES, Kirklin JW, Naftel DC, Svensson LG, Coselli JS, Safi HJ. Surgery for acute dissection of ascending aorta. Should the arch be included? J Thorac Cardiovasc Surg. 1992 Jul;104(1):46-59. — View Citation

Czerny M, Zimpfer D, Fleck T, Hofmann W, Schoder M, Cejna M, Stampfl P, Lammer J, Wolner E, Grabenwoger M. Initial results after combined repair of aortic arch aneurysms by sequential transposition of the supra-aortic branches and consecutive endovascular stent-graft placement. Ann Thorac Surg. 2004 Oct;78(4):1256-60. — View Citation

Estrera AL, Miller CC 3rd, Huynh TT, Porat E, Safi HJ. Neurologic outcome after thoracic and thoracoabdominal aortic aneurysm repair. Ann Thorac Surg. 2001 Oct;72(4):1225-30; discussion 1230-1. — View Citation

Gorlitzer M, Weiss G, Meinhart J, Waldenberger F, Thalmann M, Folkmann S, Moidl R, Grabenwoeger M. Fate of the false lumen after combined surgical and endovascular repair treating Stanford type A aortic dissections. Ann Thorac Surg. 2010 Mar;89(3):794-9. doi: 10.1016/j.athoracsur.2009.11.054. — View Citation

Halstead JC, Meier M, Etz C, Spielvogel D, Bodian C, Wurm M, Shahani R, Griepp RB. The fate of the distal aorta after repair of acute type A aortic dissection. J Thorac Cardiovasc Surg. 2007 Jan;133(1):127-35. Epub 2006 Dec 4. — View Citation

Hirotani T, Nakamichi T, Munakata M, Takeuchi S. Routine extended graft replacement for an acute type A aortic dissection and the patency of the residual false channel. Ann Thorac Surg. 2003 Dec;76(6):1957-61. — View Citation

Jakob H, Tsagakis K, Tossios P, Massoudy P, Thielmann M, Buck T, Eggebrecht H, Kamler M. Combining classic surgery with descending stent grafting for acute DeBakey type I dissection. Ann Thorac Surg. 2008 Jul;86(1):95-101. doi: 10.1016/j.athoracsur.2008.03.037. — View Citation

Kazui T, Washiyama N, Muhammad BA, Terada H, Yamashita K, Takinami M, Tamiya Y. Total arch replacement using aortic arch branched grafts with the aid of antegrade selective cerebral perfusion. Ann Thorac Surg. 2000 Jul;70(1):3-8; discussion 8-9. — View Citation

Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest. 2002 Jul;122(1):311-28. Review. — View Citation

Liu ZG, Sun LZ, Chang Q, Zhu JM, Dong C, Yu CT, Liu YM, Zhang HT. Should the "elephant trunk" be skeletonized? Total arch replacement combined with stented elephant trunk implantation for Stanford type A aortic dissection. J Thorac Cardiovasc Surg. 2006 Jan;131(1):107-13. Epub 2005 Dec 9. — View Citation

Mizuno T, Toyama M, Tabuchi N, Wu H, Sunamori M. Stented elephant trunk procedure combined with ascending aorta and arch replacement for acute type A aortic dissection. Eur J Cardiothorac Surg. 2002 Oct;22(4):504-9. — View Citation

Park KH, Lim C, Choi JH, Chung E, Choi SI, Chun EJ, Sung K. Midterm change of descending aortic false lumen after repair of acute type I dissection. Ann Thorac Surg. 2009 Jan;87(1):103-8. doi: 10.1016/j.athoracsur.2008.09.032. — View Citation

Pochettino A, Brinkman WT, Moeller P, Szeto WY, Moser W, Cornelius K, Bowen FW, Woo YJ, Bavaria JE. Antegrade thoracic stent grafting during repair of acute DeBakey I dissection prevents development of thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2009 Aug;88(2):482-9; discussion 489-90. doi: 10.1016/j.athoracsur.2009.04.046. — View Citation

Rampoldi V, Trimarchi S, Eagle KA, Nienaber CA, Oh JK, Bossone E, Myrmel T, Sangiorgi GM, De Vincentiis C, Cooper JV, Fang J, Smith D, Tsai T, Raghupathy A, Fattori R, Sechtem U, Deeb MG, Sundt TM 3rd, Isselbacher EM; International Registry of Acute Aortic Dissection (IRAD) Investigators. Simple risk models to predict surgical mortality in acute type A aortic dissection: the International Registry of Acute Aortic Dissection score. Ann Thorac Surg. 2007 Jan;83(1):55-61. — View Citation

Sun L, Qi R, Chang Q, Zhu J, Liu Y, Yu C, Zhang H, Lv B, Zheng J, Tian L, Lu J. Surgery for acute type A dissection with the tear in the descending aorta using a stented elephant trunk procedure. Ann Thorac Surg. 2009 Apr;87(4):1177-80. doi: 10.1016/j.athoracsur.2009.01.042. — View Citation

Sun L, Qi R, Chang Q, Zhu J, Liu Y, Yu C, Zhang H, Lv B, Zheng J, Tian L, Lu J. Surgery for marfan patients with acute type a dissection using a stented elephant trunk procedure. Ann Thorac Surg. 2008 Dec;86(6):1821-5. doi: 10.1016/j.athoracsur.2008.08.026. — View Citation

Takahara Y, Sudo Y, Mogi K, Nakayama M, Sakurai M. Total aortic arch grafting for acute type A dissection: analysis of residual false lumen. Ann Thorac Surg. 2002 Feb;73(2):450-4. — View Citation

Trimarchi S, Nienaber CA, Rampoldi V, Myrmel T, Suzuki T, Mehta RH, Bossone E, Cooper JV, Smith DE, Menicanti L, Frigiola A, Oh JK, Deeb MG, Isselbacher EM, Eagle KA; International Registry of Acute Aortic Dissection Investigators. Contemporary results of surgery in acute type A aortic dissection: The International Registry of Acute Aortic Dissection experience. J Thorac Cardiovasc Surg. 2005 Jan;129(1):112-22. — View Citation

Uchida N, Shibamura H, Katayama A, Shimada N, Sutoh M, Ishihara H. Operative strategy for acute type a aortic dissection: ascending aortic or hemiarch versus total arch replacement with frozen elephant trunk. Ann Thorac Surg. 2009 Mar;87(3):773-7. doi: 10.1016/j.athoracsur.2008.11.061. — View Citation

Urbanski PP, Siebel A, Zacher M, Hacker RW. Is extended aortic replacement in acute type A dissection justifiable? Ann Thorac Surg. 2003 Feb;75(2):525-9. — View Citation

Zierer A, Voeller RK, Hill KE, Kouchoukos NT, Damiano RJ Jr, Moon MR. Aortic enlargement and late reoperation after repair of acute type A aortic dissection. Ann Thorac Surg. 2007 Aug;84(2):479-86; discussion 486-7. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary the occluded rate of false lumen by the CTA 1 year postoperatively
Secondary the survive rate by the questionnaire 3 months, 6 months, 12 months postoperatively
Secondary complication by the datum of case 1 months postoperatively
Secondary reoperation rate by the datum of case 1 year postoperatively
Secondary the growth rate of thoracic descending aorta by the CTA 3 months, 6 months, 12 months postoperatively
Secondary security index by the datum of case 7 days perioperatively
Secondary life quality by the questionnaire 3 months, 6 months, 12 months postoperatively
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